§ 878.4675 Breast implant suction retrieval system.

(a) Identification. A breast implant suction retrieval system is a prescription surgical device that uses vacuum suction to assist in the removal and containment of a ruptured silicone breast implant. (b) Classification. Class II (special controls). The special controls for this device are: (1) Animal performance testing must demonstrate that the device performs as intended and will not result in tissue injury. Testing must: (i) Demonstrate the ability to remove implants of the sizes and types specified in device labeling; and (ii) Assess tissue integrity and injury at multiple time intervals to assess tissue healing response after device use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Characterization of the range of device operation, including minimum and maximum vacuum suction parameters; (ii) Durability and integrity testing; and (iii) Characterization of control and variation of suction application. (3) Performance testing must demonstrate the sterility of the device. (4) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (5) The tissue-contacting components of the device must be demonstrated to be biocompatible. (6) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the directions for use. (7) Labeling must include the following: (i) Summary of device specifications, including vacuum suction pressure ranges and bottle capacity; and (ii) Sizes and types of implants that can be removed with the device.